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German HTA slams cagey Chiesi disclosure on Glybera bad news

This article was originally published in Scrip

Executive Summary

The G-BA, the body in charge of Germany's AMNOG health technology appraisals, is "bewildered" that it learned about a potentially damming EMA risk benefit report on Chiesi/uniQure's gene therapy Glybera from the US Security and Exchange Commission and not the company responsible for the drug. The G-BA was due to publish a resolution declaring that the orphan drug has additional therapeutic value on 16 April, but has instead decided to suspend the process.

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